SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
FDA 510(k) clearance K991995 · decided 1999-08-27
Clearance details
- K-number
- K991995
- Device name
- SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
- Applicant
- Softchrome, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-14
- Decision date
- 1999-08-27
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- MZD
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Grand Junction, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.